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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K132142
Device Name NERIA SOFT 90 INFUSION SET
Applicant
UNOMEDICAL A/S
UNIT B9, TAYLORS COURT, PARKGATE
ROTHERHAM, SOUTH YORKSHIRE,  GB S62 6NU
Applicant Contact DEIRDRE BARROW
Correspondent
UNOMEDICAL A/S
UNIT B9, TAYLORS COURT, PARKGATE
ROTHERHAM, SOUTH YORKSHIRE,  GB S62 6NU
Correspondent Contact DEIRDRE BARROW
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/11/2013
Decision Date 10/08/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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